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TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH SUBCHAPTER d: LABORATORIES AND BLOOD BANKS PART 490 ILLINOIS BLOOD BANK CODE SECTION 490.10 DEFINITIONS
Section 490.10 Definitions
"Accredited Institution" or "Accredited College or University" means a college or university located in the United States which has been accredited by one of the regional accreditation programs recognized by the U.S. Commissioner of Education or a college or university located outside the United States where the individual provides documentation that the individual's education is equivalent to that provided in the United States by: documenting that the foreign degree has been accepted by an accredited institution in the United States at which the person is or was enrolled in a graduate program; or having the individual's credentials evaluated by the Credentials Evaluation Service, Inc., Los Angeles, California.
"Act" means the Illinois Blood Bank Act (Ill. Rev. Stat. 1987, ch. 111½, pars. 601-101 et seq. as now and hereafter amended.)
"Approved Blood Bank" means, for purposes of personnel qualifications, a blood bank directed by a physician licensed to practice medicine in the state in which the blood bank is located and which is licensed by FDA (21 CFR 600-680)(1987).
"Approved Clinical Laboratory" means, for purposes of personnel qualifications, a clinical laboratory – with a director at the doctoral level – of a hospital, health department, university, medical research institution; or a clinical laboratory licensed under the Illinois Clinical Laboratory Act (Ill. Rev. Stat. 1987, ch. 111½, par. 621-101 et seq.); or a blood bank licensed under the Blood Bank Act; or a clinical laboratory licensed under the Clinical Laboratories Improvement Act of 1967 (42 U.S.C. 201 et seq. as amended by the Clinical Laboratory Amendments of 1988, P.L. 100-578, October 31, 1988) or, a clinical laboratory approved under 42 CFR 405, Subpart M, (1987).
"Demonstration of proficiency" means the blood bank meets the standards for acceptable proficiency testing as stated in Section 490.620(f) by means of on-site analysis of specimens sent to the blood bank by agencies approved by the Department for that purpose (See Section 490.620 of this Part).
"Department" means the Illinois Department of Public Health.
"Drawing Station" means a facility in a permanent location under the direction of licensed blood bank only for the collection and transient storage of blood prior to shipment to a licensed blood bank for processing, distribution, and/or administration of blood or its component parts.
"FDA" means the Food and Drug Administration.
"Full-time experience" means experience in the field being referred to consisting of a least 35 hours per week conducting activities required by the specific position or field such biological, microbiological, serological, chemical, immunohematological, radioimmunological, hematological, biophysical, cytological, pathological, toxicological or other examination of materials derived from the human body for the purposes of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of humans including determining drug use by humans, shall constitute acceptable experience.
"Hospital Licensing Act" means the Hospital Licensing Act (Ill. Rev. Stat. 1987, ch. 111½, pars. 142 et seq. as now and hereafter amended).
"Illinois Clinical Laboratory Act" means the Illinois Clinical Laboratory Act (Ill. Rev. Stat. 1987, ch. 111½, pars. 621-101 et seq. as not and hereafter amended.)
"Medical Practice Act of 1987" means the Medical Practice Act of 1987 (Ill. Rev. Stat. 1987, ch. 111, pars. 4400-01 et seq., as now and hereafter amended).
"Physician" means a person licensed in Illinois to practice medicine in all of its branches.
"Technician" means an individual who meets the educational and experience requirements set forth in Section 490.430 of this Part and who functions only under the direct supervision of a director, supervisor or technologist.
"Technologist" means an individual who meet the educational and experience requirements set forth in Section 490.420 of this Part and who performs tests requiring the exercise of judgment and responsibility with minimal supervision by the director or supervisor only in those areas of testing in which the technologist is qualified by education, training and experience. |